Human C1 Esterase Inhibitor (C1-INH) in Subjects With Acute Abdominal or Facial Hereditary Angioedema (HAE) Attacks
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ClinicalTrials.gov Identifier: NCT00168103 |
Recruitment Status :
Completed
First Posted : September 14, 2005
Results First Posted : August 24, 2010
Last Update Posted : March 31, 2015
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Condition or disease | Intervention/treatment | Phase |
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Hereditary Angioedema | Biological: C1 Esterase Inhibitor Biological: Placebo | Phase 2 Phase 3 |
For each subject, only a single abdominal or facial attack was treated and evaluated. After receiving treatment, subjects were observed for a minimum of 4 hours, after which they could be discharged from the study center if they reported onset of symptom relief. Starting from 4 hours after treatment, subjects who reported insufficient or no symptom relief could receive a second dose of double-blind treatment (called "rescue medication") as follows: C1-INH 20 U/kg bw for subjects initially receiving placebo, C1-INH 10 U/kg bw for subjects initially receiving C1-INH 10 U/kg bw, and placebo for subjects initially receiving C1-INH 20 U/kg bw.
The study was defined to be successful if the primary outcome measure and at least one of the secondary outcome measures were met in the comparison between the C1-INH 20 U/kg bw group and the Placebo group.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 126 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Human Pasteurized C1 Esterase Inhibitor Concentrate (CE1145) in Subjects With Congenital C1-INH Deficiency and Acute Abdominal or Facial HAE Attacks |
Study Start Date : | June 2005 |
Actual Primary Completion Date : | October 2007 |
Actual Study Completion Date : | December 2007 |

Arm | Intervention/treatment |
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Experimental: C1-INH 10 U/kg bw
10 Units (U)/kg body weight (bw) dose
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Biological: C1 Esterase Inhibitor
Single application of C1-INH administered intravenously by slow injection or infusion at a recommended rate of 4mL/min.
Other Names:
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Experimental: C1-INH 20 U/kg bw
20 U/kg bw dose
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Biological: C1 Esterase Inhibitor
Single application of C1-INH administered intravenously by slow injection or infusion at a recommended rate of 4mL/min.
Other Names:
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Placebo Comparator: Placebo |
Biological: Placebo
Single application of physiological saline solution equivalent to the volume calculated for subjects in the C1-INH 20 U/kg bw arm.
Other Name: Physiological saline solution |
- Time to Start of Relief of Symptoms From HAE Attack [ Time Frame: Up to 24 h after start of study treatment ]The start of symptom relief was determined by subject self-assessment. Time to start of symptom relief was set to 24 hours if the subject received rescue medication (blinded study medication, narcotic analgesics, antiemetics, open-label C1-INH, or fresh frozen plasma) at any time point after the start of study treatment but before start of relief.
- Number of Subjects With Worsened Intensity of Clinical HAE Symptoms [ Time Frame: Baseline and between 2 and 4 h after start of study treatment ]Includes any worsening of intensity of at least 1 of the HAE symptoms present at baseline. Routinely checked symptoms included pain, nausea, vomiting, cramps, and diarrhea.
- Number of Vomiting Episodes [ Time Frame: Within 4 h after start of study treatment ]
- Time to Complete Resolution of All HAE Symptoms, Including Pain [ Time Frame: Up to 24 h after start of study treatment ]Complete resolution of symptoms was determined by subject self-assessment.
- Number of Subjects Receiving Rescue Study Medication [ Time Frame: Within 4 h after start of study treatment ]

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Ages Eligible for Study: | 6 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Documented congenital C1-INH deficiency
- Acute facial or abdominal HAE attack
Key Exclusion Criteria:
- Acquired angioedema
- Treatment with any other investigational drug within the last 30 days before study entry
- Treatment with any C1-INH concentrate within the previous 7 days

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00168103
United States, California | |
Study Site | |
Granada Hills, California, United States, 91344 | |
United States, Florida | |
Study Site | |
Weston, Florida, United States, 33331 | |
United States, Georgia | |
Study Site | |
Atlanta, Georgia, United States, 30342 | |
United States, Idaho | |
Study Site | |
Idaho Falls, Idaho, United States, 83404 | |
United States, Illinois | |
Study Site | |
Chicago, Illinois, United States, 60612 | |
United States, Louisiana | |
Study Site | |
Shreveport, Louisiana, United States, 71130 | |
United States, Massachusetts | |
Study Site | |
Boston, Massachusetts, United States, 02115 | |
United States, Minnesota | |
Study Site | |
Plymouth, Minnesota, United States, 55411 | |
United States, Nebraska | |
Study Site | |
Omaha, Nebraska, United States, 68131 | |
United States, New York | |
Study Site | |
Bronx, New York, United States, 10461 | |
United States, Ohio | |
Study Site | |
Cincinnati, Ohio, United States, 45231 | |
United States, Oklahoma | |
Study Site | |
Tulsa, Oklahoma, United States, 74133 | |
United States, Oregon | |
Study Site | |
Eugene, Oregon, United States, 97401 | |
United States, Pennsylvania | |
Study Site | |
Hershey, Pennsylvania, United States, 17033 | |
United States, South Dakota | |
Study Site | |
Rapid City, South Dakota, United States, 57702 | |
United States, Texas | |
Study Site | |
Dallas, Texas, United States, 75230 | |
United States, Washington | |
Study Site | |
Bellingham, Washington, United States, 98225 | |
Argentina | |
Study Site | |
Buenos Aires, Argentina | |
Australia | |
Study Site | |
Westmead, Australia | |
Bulgaria | |
Study Site | |
Plovdiv, Bulgaria | |
Study Site | |
Sofia, Bulgaria | |
Canada | |
Study Site | |
Edmonton, Canada | |
Study Site | |
Ottawa, Canada | |
Czech Republic | |
Study Site | |
Brno, Czech Republic | |
Hungary | |
Study Site | |
Budapest, Hungary | |
Israel | |
Study Site | |
Tel Hashomer, Israel | |
Macedonia, The Former Yugoslav Republic of | |
Study Site | |
Skopje, Macedonia, The Former Yugoslav Republic of | |
Poland | |
Study Site | |
Grodzisk Mazowiecki, Poland | |
Study Site | |
Krakow, Poland | |
Romania | |
Study Site | |
Tirgu-Mures, Romania | |
Russian Federation | |
Study Site 1 | |
Moscow, Russian Federation | |
Study Site 2 | |
Moscow, Russian Federation | |
Study Site 3 | |
Moscow, Russian Federation | |
Spain | |
Study Site | |
Madrid, Spain | |
Sweden | |
Study Site | |
Goeteborg, Sweden | |
United Kingdom | |
Study Site | |
London, United Kingdom |
Study Director: | Program Director, Clinical R&D | CSL Behring |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Global Head Clinical Research & Development, CSL Behring |
ClinicalTrials.gov Identifier: | NCT00168103 |
Other Study ID Numbers: |
CE1145_3001 2004-001186-17 ( EudraCT Number ) |
First Posted: | September 14, 2005 Key Record Dates |
Results First Posted: | August 24, 2010 |
Last Update Posted: | March 31, 2015 |
Last Verified: | February 2011 |
C1 Inhibitor Hereditary angioedema Acute HAE attack |
Angioedema Angioedemas, Hereditary Vascular Diseases Cardiovascular Diseases Urticaria Skin Diseases, Vascular Skin Diseases Hypersensitivity, Immediate Hypersensitivity |
Immune System Diseases Genetic Diseases, Inborn Complement C1s Complement C1 Inhibitor Protein Complement C1 Inactivator Proteins Immunologic Factors Physiological Effects of Drugs Complement Inactivating Agents Immunosuppressive Agents |